đź“‹ FDA Reference
Additive Orthopaedics Locking Lattice Plate
Additive Orthopaedics
Summary: The Additive Orthopaedics Locking Lattice Plate is a medical device used for fracture fixation, particularly in osteoporotic patients. It is primarily used by orthopedic surgeons to stabilize complex fractures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K170214 ↗
Decision Date ?
April 13, 2017
Product Code ?
HRS
Device Class ?
Class 2
Evidence ?
0 studies
The Additive Orthopaedics Locking Lattice Plate was cleared by the FDA via the 510(k) pathway on April 13, 2017. It is manufactured by Additive Orthopaedics and is classified as a Class II device under product code HRS.
What It Is
The Additive Orthopaedics Locking Lattice Plate is a fracture fixation device designed using additive manufacturing techniques. It features a lattice structure that provides enhanced stability and promotes bone ingrowth. This innovative design is particularly beneficial for patients with osteoporotic bone, where traditional fixation methods may fail.
FDA-Cleared Indications
- Fixation of fractures using a locking plate and compatible screws.
- Use in fracture fixation where stable internal fixation is required, including certain complex fractures.
- Use in patients with osteoporotic or otherwise compromised bone, when consistent with the device's cleared labeling.
Clinical Applications
- Internal fixation of selected proximal humerus fractures.
- Stabilization of complex fractures requiring plate-and-screw fixation.
- Fracture fixation in patients with osteoporotic or poor-quality bone.
- Use during open reduction and internal fixation performed by an orthopedic surgeon.
Practical Considerations
- The system is available in multiple plate sizes and configurations; the surgeon selects the option that matches the fracture pattern and patient anatomy.
- Use requires compatible locking screws and standard orthopedic fixation instrumentation according to the manufacturer's instructions for use.
- The lattice design may have handling and positioning characteristics that differ from conventional solid plates.
- MRI safety and MRI-conditional conditions must be verified in the current device labeling; do not assume that the implant is safe for MRI without this information.
- Contraindications, bone quality, infection risk, fracture pattern, and the patient's ability to follow postoperative restrictions should be assessed before implantation.
Related Literature
The linked study examined the biomechanical performance of additively manufactured proximal humerus fracture fixation plates. It compared conventional locking plates with novel designs featuring integrated struts for medial support. The study found that lattice structures may offer enhanced stability and promote bone ingrowth. However, the study was limited by its use of synthetic bones and may not fully replicate clinical conditions.
Frequently Asked Questions
What is the Additive Orthopaedics Locking Lattice Plate used for?
It is used for the fixation of complex fractures, particularly in osteoporotic patients.
What specialties typically use this device?
Orthopedic surgeons commonly use this device in fracture fixation procedures.
What are the FDA-cleared indications?
The device is indicated for stabilizing fractures, especially in patients with osteoporotic bone.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.